Paediatric addendum to CHMP guideline on clinical investigation of medicinal products in the treatment of lipid disorders

We have adopted this International Scientific Guideline - EMA/CHMP/494506/2012 (EMEA/CHMP/EWP/213057/2010)

Last updated

17 January 2025

About this guideline

Overseas effective date: 20 March 2013

Replaces: EMEA/CHMP/EWP/350495/2009 Concept paper (provided for information 26 March 2010)

Note: This document is an addendum to the Guideline on clinical investigation of medicinal products in the treatment of lipid disorders(EMA/CHMP/748108/2013, Rev. 3). It highlights differences from adult patients with lipid disorders and points out specific paediatric issues.

Categories: Clinical efficacy and safety | Cardiovascular system | Lipid disorders

TGA annotations: Nil

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